AI, Medical Devices, Digital Health, and the Future of Healthcare Transactions
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions.
The life sciences industry is built on breakthroughs and partnerships. From early-stage biotech startups to established medtech and pharma companies, success often depends on navigating complex business transactions, securing funding, protecting intellectual property, and aligning with regulatory requirements.
At Husch Blackwell, we’ve worked alongside drug manufacturers, device companies, digital health innovators, academic medical centers, CROs
On February 25, 2025, the U.S. Department of Justice filed a False Claims Act (FCA) complaint against an Idaho home health agency and its owner, alleging that a series of Paycheck Protection Program (PPP) loan applications were fraudulent because the home health agency did not disclose in the applications that the home health agency was making improper claims to Idaho Medicaid at the time it applied for the loans.
On January 17, 2025, the ERISA Industry Committee (ERIC) filed a lawsuit in the U.S. District Court for the District of Columbia, claiming that the 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule oversteps legal bounds, breaches the Administrative Procedure Act (APA), improperly delegates the Departments of Labor, Health and Human Services and Treasury’s (Departments) executive power to private entities, and violates the Due Process Clause. ERIC argues that under the Mental Health Parity Act of 1996, the plan was not obligated to assess any disparate impact that a term, applicable to both medical/surgical (M/S) and mental health and substance use disorder (MH/SUD) benefits, might have had on access to MH/SUD benefits. The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) similarly maintained the disparate treatment standard of liability, rather than the disparate impact standard. Moreover, the Departments acknowledged in the 2013 regulations that “disparate results alone” did not constitute a parity violation.
Last fall, private equity and hedge fund investors were given a reprieve from the prospect of increased oversight of healthcare transactions when California Governor Gavin Newsom unexpectedly vetoed Assembly Bill 3129 (AB 3129). That bill would have required review and approval by the California Attorney General of certain healthcare transactions involving private equity groups and hedge funds and imposed limitations on contractual relationships between investors and healthcare providers. On February 12, 2025, Senator Christopher Cabaldon (D-Sacramento) introduced Senate Bill 351 (SB 351), which revives aspects of AB 3129 relating to relationships between private equity groups and hedge funds and physician and dental practices, reinforcing California’s existing corporate practice of medicine and corporate practice of dentistry bars.
On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), issued proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule (the Proposed Rule) to strengthen the cybersecurity protections that HIPAA-regulated entities are required to maintain for electronic protected health information (ePHI).
On January 8, 2025, a federal grand jury in Virginia returned an indictment against a hospital. This rare criminal event in healthcare alleges that Chesapeake Regional Medical Center conspired to defraud the United States and committed healthcare fraud. Hospitals are almost never criminally charged, as federal investigations into hospitals are nearly always civil proceedings under the False Claims Act. This post explains how this hospital’s alleged actions rose to the level that merited criminal indictment.
On November 15, 2024, the California Board of Pharmacy issued a public notice of its intent to modify Cal. Code Regs. tit. 16 § 1708.2, which governs the discontinuation of pharmacy businesses in California. The regulation currently states:
“Any permit holder shall contact the board prior to transferring or selling any dangerous drugs, devices or
Keypoint: With the increased frequency and severity of cyberattacks against healthcare systems, state and federal agencies strive to improve cybersecurity controls with varied success.
In November 2023, New York Governor Kathy Hochul announced proposed regulations that would be the first state regulations for hospitals in New York. The governor described the proposed regulation as a “nation-leading blueprint” that would complement the federal Health Insurance Portability and Accountability Act (HIPAA) Security Rule enforced by the U.S. Department of Health and Human Services (HHS).
On September 9, 2024, the U.S. Department of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued a Final Rule clarifying and adding additional requirements on health plans to provide equitable access to health insurance coverage for treatment of mental health and substance use disorders (SUDs), as required by the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and implementing regulations at 45 C.F.R. Part 146 and 147 (the 2024 Final Rule).
MHPAEA is a federal law that prevents group health plans and health insurance issuers (collectively, Health Plans) that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than it does for a medical condition or surgical procedure. This means that Health Plans cannot impose additional financial requirements or apply non-quantitative treatment limitations (NQTLs) to these benefits more stringently than those applied to medical/surgical benefits.